| |  Online-Ressource |
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| Verfasst von: | Li, Shiyue [VerfasserIn]  |
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| | Wang, Guangfa [VerfasserIn] |
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| | Wang, Changhui [VerfasserIn] |
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| | Gao, Xinglin [VerfasserIn] |
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| | Jin, Faguang [VerfasserIn] |
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| | Yang, Huaping [VerfasserIn] |
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| | Han, Baohui [VerfasserIn] |
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| | Zhou, Rui [VerfasserIn] |
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| | Chen, Chengshui [VerfasserIn] |
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| | Chen, Liangan [VerfasserIn] |
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| | Bai, Chunxue [VerfasserIn] |
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| | Shen, Huahao [VerfasserIn] |
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| | Herth, Felix [VerfasserIn] |
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| | Zhong, Nanshan [VerfasserIn] |
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| Titel: | The REACH trial |
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| Titelzusatz: | a randomized controlled trial assessing the safety and effectiveness of the Spiration® Valve System in the treatment of severe emphysema |
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| Verf.angabe: | Shiyue Li, Guangfa Wang, Changhui Wang, Xinglin Gao, Faguang Jin, Huaping Yang, Baohui Han, Rui Zhou, Chengshui Chen, Liangan Chen, Chunxue Bai, Huahao Shen, Felix J. F. Herth, Nanshan Zhong |
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| Jahr: | 2019 |
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| Jahr des Originals: | 2018 |
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| Umfang: | 12 S. |
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| Teil: | volume:97 |
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| | year:2019 |
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| | number:5 |
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| | pages:416-427 |
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| | extent:12 |
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| Fussnoten: | Published online: December 14, 2018 ; Gesehen am 13.11.2019 |
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| Titel Quelle: | Enthalten in: Respiration |
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| Ort Quelle: | Basel : Karger, 1944 |
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| Jahr Quelle: | 2019 |
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| Band/Heft Quelle: | 97(2019), 5, Seite 416-427 |
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| ISSN Quelle: | 1423-0356 |
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| Abstract: | <b><i>Background:</i></b> Chronic obstructive pulmonary disease (COPD) has become a leading cause of morbidity and mortality in China, with tobacco smoke, air pollution, and occupational biohazards being the major risk factors. <b><i>Objectives:</i></b> The REACH trial is a multicenter, prospective, randomized controlled trial undertaken in China to assess the safety and effectiveness of the Spiration® Valve System (SVS) compared to standard medical care in COPD patients with severe emphysema. <b><i>Methods:</i></b> Patients with severe airflow obstruction, hyperinflation, and severe dyspnea with interlobar fissure integrity were evaluated for enrollment. A total of 107 subjects were randomized in a 2: 1 allocation ratio to either the treatment group (SVS valves and medical management) or the control group (medical management alone). <b><i>Results:</i></b> The 3-month primary endpoint showed statistically significant improvement in forced expiratory volume in 1 s in the treatment group compared to the control group (0.104 ± 0.18 vs. 0.003 ± 0.15 L, <i>p</i> = 0.001), with the difference being durable through 6 months. Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL). Exercise function and quality of life measures improved in the treatment group, but showed a deterioration in the control group. The serious adverse event (SAE) rate was 33% in the treatment group and 24.2% in the control group. The predominance of SAEs were acute exacerbations of COPD in both groups. There was 1 death in the control group and no deaths in the treatment group. <b><i>Conclusion:</i></b> The SVS represents a novel approach for the treatment of severe emphysema with a clinically acceptable risk-benefit profile. |
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| DOI: | doi:10.1159/000494327 |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
Volltext ; Verlag ; Resolving-System: https://doi.org/10.1159/000494327 |
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| | Volltext: https://www.karger.com/Article/FullText/494327 |
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| | DOI: https://doi.org/10.1159/000494327 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| K10plus-PPN: | 1681803941 |
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| Verknüpfungen: | → Zeitschrift |
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